Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Drug Combination Treatment (Capecitabine, Oxaliplatin, Fluorouracil, Irinotecan) Guided by Liquid Biopsy Testing in Patients with Stage III and High-Risk Stage II Colon Cancer

Verified siteFast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with colon cancer, specifically those with stage III or high-risk stage II disease who have undergone surgery. The study aims to determine if a special blood test called liquid biopsy can help guide treatment decisions after surgery. This test looks for small pieces of tumor DNA in the blood to monitor if the cancer might return.

The treatment plan includes several anti-cancer medications that work in different ways to fight cancer cells. These medications are capecitabine (taken as tablets by mouth), oxaliplatin (given through a vein as an infusion), fluorouracil (given through a vein), and irinotecan (given through a vein as an infusion). The specific combination of these medications will be determined based on the results of the blood tests.

Throughout the study, participants will have regular blood samples taken to check for signs of cancer using the liquid biopsy test. They will also have routine medical check-ups and imaging tests to monitor their health. The study will track how well patients do over time, particularly focusing on whether they remain cancer-free for two years after their surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Confirmation of stage III or high-risk stage II colon cancer diagnosis through tissue examination

    Verification of normal organ functions

    Assessment of physical condition using ECOG performance scale (measure of daily living abilities)

    Collection of blood sample for liquid biopsy (blood test to detect cancer DNA)

  2. Step 2

    Treatment preparation

    Review of original tumor tissue sample results

    Completion of quality of life questionnaires (QLQ-C30 and CR-29)

    For women of childbearing age: pregnancy test and discussion of contraception methods

  3. Step 3

    Treatment administration

    Receipt of medications through different methods:

    Capecitabine: tablets taken by mouth

    Oxaliplatin: medicine given through vein infusion

    Fluorouracil: medicine given through vein injection or infusion

    Irinotecan: medicine given through vein infusion

  4. Step 4

    Monitoring period

    Regular blood samples for liquid biopsy testing

    Assessment of treatment side effects using standard criteria

    Regular physical examinations and imaging tests

    Completion of quality of life questionnaires at specified intervals

  5. Step 5

    Follow-up period

    Continued monitoring for up to 2-3 years

    Regular assessments to check for signs of disease

    Final evaluation at study completion

    The study continues until July 2027

Who can join the trial?

9 criteria

  • Must sign written informed consent for the Pegasus trial
  • Must be 18 years or older

  • Must have confirmed stage III or T4N0 stage II colon cancer that is:

    • Located at least 12 cm from the anal opening
    • Above the peritoneal reflection (outer lining of the abdomen)
    • Suitable for surgery
  • Must have available FFPE tumor tissue (tumor sample preserved in paraffin wax)
  • Must have blood plasma sample collected before surgery
  • Must agree to undergo all required liquid biopsies (blood tests to detect cancer cells)
  • Must have good physical function (ECOG performance status 0-1), meaning able to carry out all or most daily activities
  • Must have normal organ function

  • For women who can become pregnant:

    • Must complete a pregnancy test
    • Must agree to use reliable birth control methods

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 75 years
  • Previous diagnosis of any other type of cancer in the past 5 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Presence of metastatic disease (cancer that has spread to other parts of the body) at diagnosis
  • Inability to undergo surgery for colon cancer
  • Presence of microsatellite instability (MSI) in tumor tissue (a specific genetic characteristic of the tumor)
  • Pregnancy or breastfeeding
  • Severe mental illness that could affect the ability to provide informed consent
  • Participation in other clinical trials within 30 days before enrollment
  • Known allergy or hypersensitivity to study medications
  • Significant heart, liver, or kidney disease that could interfere with study participation
  • Inability to provide blood samples for liquid biopsy (a blood test that looks for cancer cells or cancer DNA)
  • Lack of willingness to follow study procedures and follow-up visits
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Capecitabine

    is a chemotherapy medicine taken by mouth as tablets. Once inside the body it is converted, mainly within the tumour itself, into fluorouracil, a substance that blocks cancer cells from making the building blocks of their DNA, so they can no longer grow and divide. In this trial it is given after surgery, alone or together with oxaliplatin, to destroy any colon cancer cells that may remain in the body.

  • Oxaliplatin

    is a platinum-based chemotherapy medicine given as a drip (infusion) into a vein. It attaches to the DNA inside cancer cells and forms links that prevent the cells from copying their genetic material, which stops them from multiplying and causes them to die. In this trial it is combined with capecitabine or fluorouracil as part of the treatment given after colon cancer surgery.

  • Fluorouracil

    is a long-established chemotherapy medicine given by injection or infusion into a vein. It interferes with the way cancer cells build and repair their DNA, so the rapidly dividing tumour cells die. In this trial it is used in combination with other chemotherapy medicines, with the choice and intensity of treatment guided by blood tests that look for traces of tumour DNA.

  • Irinotecan

    is a chemotherapy medicine given as an infusion into a vein. It blocks an enzyme that cancer cells need to untangle their DNA when they divide, causing breaks in the DNA that kill the cells. In this trial it is part of a stronger chemotherapy combination given to patients whose blood tests suggest a higher risk that the colon cancer could return.

What is already known about the treatment

  • CAPECITABINE

    It is taken by mouth as tablets, usually given in a dose of 2500 mg/m². The drug is an approved chemotherapy that has been studied for many years in colorectal cancer. It works because the body changes it into 5‑fluorouracil, which blocks the enzyme needed to make DNA, slowing tumor growth. Capecitabine belongs to the antimetabolite class, specifically the fluoropyrimidines.

  • OXALIPLATIN

    It is given by intravenous infusion at a dose of about 85 mg/m². Oxaliplatin is an approved drug with extensive use in colon cancer treatment and many published studies. It contains platinum that attaches to DNA and creates cross‑links, preventing the cancer cells from copying their DNA. Oxaliplatin is classified as a platinum‑based chemotherapy agent.

  • FLUOROURACIL

    It is administered by an intravenous bolus or infusion, typically at 1600 mg/m². Fluorouracil is a long‑standing, widely approved chemotherapy for colorectal and other solid tumors. The drug mimics a building block of DNA and blocks an enzyme called thymidylate synthase, which stops DNA and RNA formation in tumor cells. It is an antimetabolite belonging to the fluoropyrimidine group.

  • IRINOTECAN

    It is given as an intravenous infusion, usually at 100 mg/m². Irinotecan is an approved chemotherapy with a solid record in clinical studies for colorectal cancer. It blocks an enzyme called topoisomerase I, which is needed for DNA to unwind, leading to breaks in the cancer cell’s DNA. Irinotecan is classified as a topoisomerase‑I inhibitor in the chemotherapy class.

Investigated diseases

Colon cancer – A disease that begins in the large intestine (colon), where healthy cells in the colon start to grow uncontrollably and form tumors. It typically develops slowly over several years, often starting as small, noncancerous clumps of cells called polyps. The cancer usually affects the inner wall of the colon first, and as it grows, it can spread through the different layers of the colon wall. The disease can develop in any part of the colon, which is the final part of the digestive tract. When caught early, the disease is often confined to the colon, but over time it can spread to nearby structures and other organs.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517704-10-00Estimated enrolment156 patientsSponsorIfom Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.